Company
Korea (the Republic of)CG Bio Co., Ltd., Hwaseong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for CG Bio Co., Ltd. in Hwaseong, -. 2 FDA inspections on record, 1 Form 483, last inspected September 03, 2026.
Company Profile
This profile covers CG Bio Co., Ltd. based in Hwaseong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 11, 2025. Last inspected September 3, 2026.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 3, 2026 | Not classified | Biologics | 1341700 |
| September 11, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1281106 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
CG Bio Co., Ltd.
FEI Number
3017036472
Address
C, D Dong, 29 Jeyakdanji-Ro; Hyangnam-Eup, Hwaseong, - -, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 66e90297-b8db-4f9f-879b-eb12285afbb1